Anchoring system for luer lock connector

ABSTRACT

An anchoring system includes a simply-structured device which permits a portion of a catheter or similar medical article to be easily anchored to a patient, desirably without the use of tape or needles and suture. An anchoring system for an elongated medical article comprises an anchor pad and a retainer mounted upon the anchor pad. The retainer includes a channel into which the medical article to be retained is placed. The retainer is attached to an anchor pad including an adhesive bottom surface, which can be attached to the patient&#39;s skin. A medical article is secured within a channel by retaining at least one radially extending member on the medical article.

RELATED APPLICATIONS

This application is a continuation application of copending applicationSer. No. 09/585,526 filed on Jun. 1, 2000 now U.S. Pat. No. 6,428,515.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates in general to a medical article anchoringsystem. In one mode, the present invention involves a catheterizationsystem that interconnects an indwelling catheter with medical tubing andsecurely anchors the interconnection to a patient's skin.

2. Description of the Related Art

Medical treatment of patients commonly involves the use ofpercutaneously inserted catheters to deliver fluids directly into thebloodstream, a specific organ or an internal location within thepatient, or to monitor vital functions of the patient. For instance,short, peripherally-inserted, intra-arteriovenous catheters are commonlyused to direct fluids and/or medications directly into the bloodstreamof the patient.

The fluid (e.g., parenteral liquid, medication, etc.) typically drainsfrom a container positioned above the patient to feed under gravity oris delivered via an infusion pump. The fluid flows through tubing andthence into the indwelling catheter. The catheter and the fluid tubingare commonly removably attached to each other by a conventional luerlock connection.

A luer lock connection generally includes a male luer connector with atapered conical portion that is adapted to fit into a correspondinglyshaped receptacle of a female luer connector (i.e., a hub). A spin nutis commonly disposed on the male luer connector and is rotatablerelative to the tapered conical portion. The spin nut includes internalthreads that are adapted to engage external threads on the female luerconnector to lock together the luer connectors. When properly engaged,the conical portion fits tightly within the receptacle to produce asealed interconnection.

A healthcare provider can experience difficulty at times breaking theseal between the engaged conical portion and the hub of the luer lockconnectors when disconnecting the male luer connector from the femaleluer connector. In order to aid such disconnection, some luer lockconnectors include spin nuts that can slide axially between a distalposition, in which the spin nut can freely rotate relative to thecoupled luer connectors, and a proximal position, in which the spin nutand male luer connector are rotationally locked. The rotational lock isprovided to assist in breaking the sealed coupling between thecorresponding surfaces of the conical portion and the hub of theinterengaged luer lock connectors.

An example of this type of luer lock connector is described in U.S. Pat.No. 5,620,427, which issued Apr. 15, 1997 to Werschmidt et al. (referredto below as “the '427 patent”). The disclosed connector provides taperedengagement surfaces providing a gradual frictional engagement whentightening the spin nut to minimize inadvertent reverse rotation andloosening of the spin nut. Also, a plurality of axially extendingsplines for engagement with a plurality of inwardly, radially directedribs on the spin nut allow positive rotationally locking of the spin nutand the male luer connector when the spin nut is in a proximal position.The spin nut, when locked with the male luer connector, provides greaterleverage to produce more torque on the male luer connector to break thesealed coupling.

In common practice, a healthcare provider uses adhesive, foam orsurgical tape to maintain the luer lock connector, and thus thecatheter, in place on the skin of the patient. The healthcare providerwraps a thin piece of tape around the luer lock connector and then formsa “chevron” with the tape, placing the ends next to the sides of theindwelling catheter. The healthcare provider then places one piece oftape across and over the connector, forms a loop in the tubing, placesanother piece of tape across the tubing loop, and places yet anadditional piece of tape over the catheter hub and the tubing sectionthat has been looped around and extends next to the indwelling catheter.This step forms a safety loop in the tubing so that any tension appliedto the tubing does not directly pass to the catheter cannula, but ratheris absorbed by the slack of the safety loop. Subsequently, thehealthcare provider typically covers the insertion site and theindwelling catheter with a transparent dressing.

The entire taping and dressing procedure takes several minutes of thehealthcare provider's valuable time. In addition, the catheterizationprocess often requires relatively frequent disconnection between thecatheter and the fluid supply tube, as well as dressing changes. Forinstance, intravenous catheterization is frequently maintained forseveral days, depending upon the condition of the patient. The tubing isgenerally replaced every 48 to 72 hours in order to maintain thesterility of the fluid and the free-flow of the fluid through thetubing. A healthcare provider thus must frequently change the tubing andre-tape the connection. The healthcare provider also must frequentlyclean the insertion site about the indwelling catheter and change thedressings. Moreover, the tape, which secures the catheter to the skin ofthe patient, often covers the cannula insertion point. The healthcareprovider must remove the tape to inspect the insertion point forinflammation or infection, and must then repeat the above-describedtaping procedure.

The healthcare provider thus uses a great deal of valuable timeapplying, removing and reapplying tape. The frequent application andremoval of the tape also commonly excoriates the patient's skin aboutthe insertion site.

In addition, the traditional method of intravenous cathetersecurement-surgical tape and transparent dressings alone—have not alwaysprevented catheter migration and/or dislodgment. Taped intravenouscatheters are also easily pulled out during a “routine” dressing change,especially by inexperienced healthcare providers. And if the cathetermigrates too far or dislodgment occurs, the healthcare provider mustreplace the catheter, thus exacerbating the time and expense required tomaintain the intravenous feed. Such catheter restarts also poses therisk of needle stick to the healthcare provider.

Prior securement methods have not served the patient as well. Surgicaltape or foam strips are uncomfortable. Many patients also do not restcomfortably and worry about catheter dislodgment when they move, whenonly tape and a dressing secure the catheter in place.

Several additional drawbacks result from the use of tape to stabilizethe catheter. One is contamination. Healthcare providers often tear offsmall strips of tape and place them on the hand rail on the patient'sbed. Clostridium and other bacteria commonly exist on these surfaces andcan be transferred to the patient's skin in the proximity of theinsertion site.

In addition, tape securement requires the healthcare provider to handlethe tape while wearing protective latex gloves. Tearing adhesive tapetends to produce microscopic and/or visible holes in the gloves and thusdestroys glove barrier protection.

A number of catheter securement systems have been developed to obviatethe need for frequent application of tape to secure a catheter to apatient. One such securement system is disclosed in U.S. Pat. No.5,456,671, issued Dec. 10, 1995, to Steven F. Bierman, M. D.(hereinafter referred to as “the '671 patent”). The preferred form ofthe securement system disclosed in this patent involves a retainerhaving a plurality of lateral slots. Each slot has a similar size and isdesigned to receive a collar of an associated catheter connector oradaptor. The cooperating structure of the connector and the retainer,i.e., the slots and the collar, arrests longitudinal movement of theconnector through the retainer, and permits quick insertion of theconnector into the retainer. The healthcare provider need not worryabout the rotational orientation of the connector above the retainer andonly need to align coarsely the collar of the connector above the seriesof slots before pushing the connector into the retainer.

The retainer, which is disclosed in the '671 patent, does not work aswell with the connector disclosed in the '427 patent. As noted above,the connector disclosed in the '427 patent has a plurality of axiallyextending splines that are spaced around a portion of the circumferenceof the connector's tubular body. At least one of these splines has alonger length than that of at least one of the other splines. Becausethe slots in the illustrated form of the retainer disclosed in the '671patent all have the same size, the rotational orientation of theconnector becomes important before the connector is inserted into theretainer. Insertion of the connector into the retainer thus requiresmore effort and care, thereby decreasing the ease of using thesecurement system disclosed in the '671 patent.

SUMMARY OF THE INVENTION

In accordance with one aspect of the present invention, an anchoringsystem provides releasable securement of a medical article (i.e., acatheter) to the patient. The releasable engagement is achieved bycooperation between a retainer, a connector or a section of the medicalarticle, and an anchor pad. This cooperation allows the medical articleto be disconnected from the anchoring system, and from the patient, forany of a variety of known purposes. For instance, a healthcare providermay want to remove the medical article from the anchoring system to easedisconnection of the medical article from the patient or to clean thepatient. The disengagement of the medical article from the anchoringsystem, however, can be accomplished without removing the anchoringsystem from the patient.

The present anchoring system also arrests movement of the medicalarticle and/or the connector with respect to the anchoring system.Transverse, lateral and longitudinal (i.e., axial) movement is generallyinhibited by the holding effect provided by the retainer. That is, theretainer generally surrounds the connector and/or section of the medicalarticle while recesses within the retainer capture projections on theconnector or the medical article.

Sturdy anchoring of the medical article thus is achieved without the useof surgical tape. Additionally, the anchoring system is attached to thepatient only once for most intravenous courses. Although the fluidsupply tubing may be replaced every 24 to 48 hours for intravenouscatheterization, the components of the present anchoring system remainsin place through multiple dressing and supply tubing changes. Thus,surgical tape need not be applied and removed from the patients' skin onmultiple occasions.

In one mode, the anchoring system is configured to securely anchor aluer lock connector of the type that includes an elongated tubular bodywith at least first and second axially extending splines. The secondaxially extending spline has a longer longitudinal length than that ofthe first axially extending spline, and the tubular body extends in alongitudinal direction from a proximal end to a distal end. Theconnector disclosed in U.S. Pat. No. 5,620,427 is an example of thistype of lure lock connector.

The anchoring system comprises a retainer and an anchor pad. Theretainer is affixed to one side of the anchor pad, and the other side ofthe anchor pad includes an adhesive layer that is adapted to secure theanchor pad and the retainer to the skin of the patient.

The retainer includes a body having first and second end portions and anintermediate portion. The intermediate portion includes a pair offlexible walls. A channel extends through at least the first and secondend portions and through the intermediate portion of the body betweenthe flexible walls. The flexible walls are deflectable away from acentral axis of the channel. The first end portion defines a firstabutment surface that lies generally normal to the central axis of thechannel, and the second end portion defines a second abutment surfacethat lies generally normal to the central axis of the channel. Thesecond abutment surface generally opposes the first abutment surface.The first and second abutment surfaces are spaced from each other by adistance greater than the longitudinal length of the second spline ofthe tubular body. At least one of the flexible walls includes third andforth abutment surfaces that lie generally normal to the central axis ofthe channel and that generally oppose each other. The third and fourthabutment surfaces are spaced apart from each other by a distance thatgenerally corresponds to the longitudinal length of the first spline ofthe tubular body.

In a preferred form, the distance between the first and second abutmentsurfaces generally corresponds to a longitudinal length measured betweenthe proximal end of the connector tubular body and a distal end of thesecond spline. The first end portion also includes a fifth abutmentsurface positioned distal of the first abutment surface. The fifthabutment surface is distanced from the second abutment surface by adistance substantially equal to the longitudinal length of the secondspline. Additionally, the other flexible wall also includes abutmentsurfaces that correspond to the third and fourth abutment surfaces.

The retainer arrests longitudinal movement of the connector with respectto the anchoring system in at least a distal direction, at least in partby retaining one or more of the splines. For example, with respect to aretainer configured in accordance the preferred mode, the second splineis captured between the second and fifth abutment surfaces when theconnector is inserted into the retainer with the second spline orienteddownwardly (i.e., facing the retainer channel) or to one side. With theconnector so situated, the second spline causes the correspondingflexible wall to deflect laterally outward and occupies the spacebetween the second and fifth abutment surfaces. When the retainer isinserted into the retainer with the second spline oriented upwardly(i.e., facing away from the retainer channel) or downward, the firstspline is captured between the abutment surfaces on one of the flexiblewalls, i.e., between the third and forth abutment surfaces. Accordingly,at least one spline is captured between a corresponding pair of abutmentsurfaces regardless of the orientation of the longer second spline(e.g., oriented upwardly, downwardly or to one side) when the connectorbody is inserted into the retainer. The corresponding pair of abutmentsurfaces thus arrest longitudinal movement of the connector in both theproximal and distal directions along the longitudinal axis.

Additionally, the first abutment surface lies just proximal of theproximal end of the connector body when the retainer receives theconnector, no matter how the second spline is situated. The firstabutment surface thus also inhibit longitudinal movement of theconnector in the proximal direction. For this reason, it is understoodthat one or more of the distal facing abutment surfaces (i.e., the thirdand fifth abutment surfaces) can be omitted from the retainer. It alsois understood that the first abutment surface can be omitted from theretainer where the retainer includes one or more of the other distalfacing abutment surfaces (e.g., the third abutment surface and/or thefifth abutment surface) to arrest movement in the proximal direction.Thus, in the preferred mode of the retainer, at least two of thesedistal facing abutment surfaces (i.e., the first, third and fifthabutment surfaces) redundantly inhibit longitudinal movement of theconnector in the proximal direction at all times when the connector bodyis inserted into the retainer channel.

The anchoring system thus is designed for a healthcare provider toquickly insert the connector into the retainer, without requiringprecise alignment or positioning of the connector on the anchoringsystem. That is, the healthcare provider need not be concerned with therotational orientation of the catheter body before inserting it into theretainer as the retainer can properly receive the connector with thelonger second spline lying at any position (e.g., upward, downward, orto one side relative to the retainer channel).

The retainer also can be configured to interact with a connector thathas splines with staggered positions along the length of the connectorbody. For example, a connector can have splines of the same length, buta distal end of one of the splines lies closer to a distal end of theconnector than a distal end of another spline. The present retainer canbe configured to hold such a connector. The ability of one retainer wallsection, which includes at least one abutment surface, to deflectrelative to the adjacent retainer wall sections, which each also includeat least one abutment surface, enables the retainer to accommodate aconnector having splines with distal end positions differing along thelength of the connector body, regardless of whether such differingdistal end positions occur because of differing lengths, a staggeredarrangement, or a combination of the two.

In addition, the retainer can be configured to interact with a connectorhaving splines of equal lengths and at the same axial location along theconnector's length. In such case, the retainer need not include all fiveabutment surfaces (e.g., it could include only two or three abutmentsurfaces).

In a variation, a catheter hub or body can include splines or otherprojections, and the retainer can be configured to receive a section ofthe catheter (e.g. the catheter hub) and to capture one or more of thecorresponding splines or projections to arrest axial movement of thecatheter.

Another aspect of the present invention involves an anchoring system fora medical article. The anchoring system comprises an anchor pad, whichhas upper and lower sides, and a retainer. The retainer is disposed onthe upper side of the anchor pad. The lower side of the anchor padincludes an adhesive surface to secure the retainer to the skin of apatient. The anchor pad also includes at least one elongated extensionwith an adhesive undersurface. The extension is adapted to be rolledupon itself around a portion of the medical article. In this manner, theextension can be used to secure a section of the medical article to theanchor pad. The secured section can thus, for example, form a safetyloop along the length of the medical article.

In accordance with an additional aspect of the present invention, acatheterization system comprises a catheter connector, a retainer and ananchor pad. The connector includes an elongated tubular body thatextends in a longitudinal direction from a proximal end to a distal endand has at least first and second axially extending splines disposed onand extending radially from the tubular body. The second axiallyextending spline has a longer longitudinal length than that of the firstaxially extending spline. In one mode, the catheter connector is locatedat the proximal end of the catheter and, in another mode, the catheterconnector is located at a distal end of a fluid tube (e.g., a fluiddelivery or drainage tube) which is to be coupled to a catheter.

The retainer includes a body and channel that extends longitudinallythrough at least a portion of the body. The body defines at least first,second, third and fourth abutment surfaces positioned along the channeland extending laterally therefrom so as to lie generally normal to anaxis of the channel. The second and third abutment surfaces are arrangedbetween the first and fourth abutment surfaces in the longitudinaldirection. The first and fourth abutment surfaces are spaced apart by adistance that is at least a long as the longitudinal length of thesecond spline, and the second and third abutment surfaces are spacedapart by a distance that is substantially equal to the longitudinallength of the first spline.

The anchor pad includes upper and lower sides. The retainer is disposedon the upper side of the anchor pad, and the lower side of the anchorpad including an adhesive surface to secure the retainer to the skin ofa patient.

Another aspect of the present invention involves an anchoring system forsecurely anchoring a medical article to a patient. The anchoring systemcomprises a retainer including a body and a channel that extendslongitudinally through at least a portion of the body. The body definesat least first, second and third abutment surfaces positioned along thechannel. The first, second and third abutment surfaces extend generallylaterally from the channel. The second abutment surface is laterallymoveable relative to one of the first and third abutment surfaces and isdisposed between the first and third abutment surfaces.

A further aspect of the present invention involves an anchoring systemfor securely anchoring to a patient a luer lock connector of the typehaving an elongated tubular body that extends in a longitudinaldirection from a proximal end to a distal end, and that includes atleast first and second axially extending splines. The anchoring systemcomprises a retainer including a body having first and second endportions and an intermediate portion between the first and second endportions. The intermediate portion includes a pair of flexible walls.Each wall is deflectable relative to the first and second end portions.A channel extends through at least the first and second end portions andthrough the intermediate portion of the body between the flexible walls.The flexible walls are deflectable away from a central axis of thechannel. The first end portion defines a first abutment surface thatlies generally normal to the central axis of the channel, and the secondend portion defines a second abutment surface that lies generally normalto the central axis of the channel and that generally opposes the firstabutment surface. At least one of the flexible walls includes a thirdabutment surface that lie generally normal to the central axis of thechannel at a location between the first and second abutment surfaces.

In a preferred mode, the anchoring system also includes an anchor pad.The retainer is affixed to one side of the anchor pad, and the otherside of the anchor pad includes an adhesive layer adapted to secure theanchor pad and the retainer to the skin of the patient. The retaineralso can be secured to the patient in other ways, for example, bysuturing, although this mode of securement is less preferred.

In accordance with a preferred method of securing a luer lock connectoron a retainer of an anchoring system, a luer lock connector is providedthat includes at least first and second splines with differing endpoints (i.e., differing points at which the splines end) along thelength of the connector. The lure lock connector is inserted into achannel of a retainer without regard to the orientation of the splinesso that the splines may be in any of a plurality of positions withrespect to the retainer when inserted. The splines are in a firstposition of the plurality of positions with the first spline facinglaterally, and are in a second position of the plurality of positionswith the first spline rotated from the first position such that thesecond spline faces laterally. The method further involveslongitudinally restraining (a) the first spline between a first pair ofabutment surfaces of the retainer if the splines are in the firstposition, or (b) the second spline between a second pair of abutmentsurfaces of the retainer if the splines are in the second position. Atleast one abutment surface of the second pair of abutment surfaces isdifferent from one of the abutment surfaces of the first pair ofabutment surfaces.

For purpose of summarizing the invention and the advantages achievedover the prior art, certain objects and advantages of the invention havebeen described above. Of course, it is to be understood that notnecessarily all such objects or advantages be achieved in accordancewith any particular embodiment of the invention. Thus, for example,those skilled in the art will recognize that the invention may beembodied or carried out in a manner that achieves or optimizes oneadvantage or group of advantages as taught herein without necessarilyachieving other objects or advantages taught or suggested herein.Additionally, further aspects, features and advantages of the presentinvention will become apparent from the detailed description of thepreferred embodiment that follows.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described with reference to the drawings of apreferred embodiment of the present anchoring system, which is intendedto illustrate and not to limit the invention. The drawings contain thefollowing figures:

FIG. 1 is an perspective view of a catheterization system in accordancewith a preferred embodiment of the present invention, being mounted onthe back of a patient's hand and securing a catheter connector to thepatient;

FIG. 2A is a top plan view of the catheter connector of thecatheterization system illustrated in FIG. 1;

FIG. 2B is a cross-sectional view of the catheter connector takenthrough line 2B—2B of FIG. 2A;

FIG. 3 is a perspective view of a retainer of the catheterization systemof FIG. 1;

FIG. 4 is a top plan view of the retainer of FIG. 3;

FIG. 5 is a bottom plan view of the retainer of FIG. 3;

FIG. 6 is an elevational side view of the retainer of FIG. 3;

FIG. 7 is an elevational proximal end view of the retainer of FIG. 3;

FIG. 8 is an elevational distal end view of the retainer of FIG. 3;

FIG. 9 is a cross-sectional view of the retainer of FIG. 4, taken alongthe 9—9 line;

FIG. 10 is a cross-sectional view of the retainer of FIG. 4, taken alongthe 10—10 line;

FIG. 11A is a top plan view of the catheterization system of FIG. 1 withthe connector inserted with splines orientated upward (the tubing, whichis illustrated in FIG. 1 as extending from the connector, has beenomitted to simplify the drawing);

FIG. 11B is a cross-sectional view of the catheterization system of FIG.11A, taken along the 11B—11B line;

FIG. 11C is a top plan view of the catheterization system of FIG. 1 withthe connector inserted with the splines rotated 90° from their positionin FIG. 11A (the tubing also has been omitted in this drawing);

FIG. 11D is a cross-sectional view of the catheterization system of FIG.11C, taken along the 11D—11D line;

FIG. 11E is a top plan view of the catheterization system of FIG. 1,with the connector inserted with the splines rotated 180° from theirposition in FIG. 11A (the tubing again has been omitted from thisdrawing);

FIG. 11F is a cross-sectional view of the catheterization system of FIG.11E, taken along the 11F—11F line; and

FIG. 12 is a cross-sectional view of the retainer of FIG. 4, taken alongthe 9—9 line, with the catheter connector being withdrawn.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present embodiment of the medical article anchoring system isdisclosed in the context of a catheterization system, and in particularin the context of a catheterization system utilizing a luer lockconnector of the type disclosed in U.S. Pat. No. 5,620,427 to Werschmidtet al. The catheterization system also can include a catheter, a tubeextension set and/or dressing materials.

The principles of the present invention, however, are not limited tocatheters or to the specific type of connector disclosed in the '427patent. Instead, it will be understood by one of skill in this art, inview of the present disclosure, that the anchoring system disclosedherein also can be successfully utilized in connection with other typesof luer connectors, including those with splines of equal lengths or ofstaggered positions along the connector body length, as noted above. Inaddition, it will be understood by one of skill in this art that theanchoring system disclosed herein also can be successfully utilized inconnection with other types of medical articles, including other typesof catheters, fluid drainage and delivery tubes, and electrical wires.For example, but without limitation, the retainer disclosed herein canbe configured to secure peripheral catheters, peripherally insertedcentral catheters, hemodialysis catheters, surgical drainage tubes,feeding tubes, chest tubes, nasogastric tubes, scopes, as well aselectrical wires or cables connected to external or implanted electronicdevices or sensors. One skilled in the art may also find additionalapplications for the devices and systems disclosed herein. Thus, theillustration and description of the anchoring system in connection witha catheterization system, which include a luer lock connector similar tothat used in U.S. Pat. No. 5,620,427, merely exemplifies one possibleapplication of the present anchoring system.

With reference now to the preferred embodiment, FIG. 1 illustrates inperspective view a catheter anchoring system 20. The anchoring system 20cooperates with a luer lock connector 22 that securely connects a tube24 (e.g., a fluid supply line) to an indwelling catheter 26. Thecooperation between the anchoring system 20 and the connector 22maintains the catheter 26 in the desired indwelling position.

The anchoring system 20 principally comprises a flexible anchor pad 28having an adhesive bottom side that attaches to the skin of a patientwhen used. The pad 28 can be attached at any number of locations on apatient's body. Thus, although FIG. 1 illustrates the anchoring system20 located on the back of a patient's hand, it can be used forcatheterization at other locations on the patient's body, e.g., on themedial side of the wrist in connection with catheterization of a radialartery or on the anterior or posterior of the patient's torso inconnection with epidural catheterization. The pad 28 supports a retainer30. The retainer 30 in turn is configured to receive and secure in placethe catheter connector 22.

To assist in the description of the components of the anchoring system,the following coordinate terms are used (see FIG. 1). A “longitudinalaxis” is generally parallel to the section of the catheter 26 orconnector 22 retained by the anchoring system 20. A “lateral axis” isnormal to the longitudinal axis and is generally parallel to the planeof the anchor pad 28. A “transverse axis” extends normal to both thelongitudinal and lateral axes. In addition, as used herein, “thelongitudinal direction” refers to a direction substantially parallel tothe longitudinal axis; “the lateral direction” refers to a directionsubstantially parallel to the lateral axis; and “the transversedirection” refers to a direction substantially parallel to thetransverse axis. The terms “proximal” and “distal”, which are used todescribe the present anchoring system, are used consistently with thedescription of the exemplifying application. Thus, proximal and distalare used in reference to the fluid supply container (not shown) attachedto a fluid supply line 24. Also, the terms “top,” “bottom,” “upper,” and“lower” are used in the context of the orientation of the anchoringsystem illustrated in FIG. 1, and are not intended to imply a limitationto the orientation that the anchoring system can assume on the patient.A detailed description of the catheterization system (including thepresent anchoring system), and its associated method of use, nowfollows.

Luer Lock Connector

With reference to FIG. 1, a luer lock coupling is formed between a luerlock connector 22 and a hub 32 of the catheter 22. Although the luerlock connector 22 is illustrated as being of the type disclosed in U.S.Pat. No. 5,620,427 to Werschmidt et al., which is hereby incorporated byreference, other types of connector and adaptors can be used as wellwith the present anchoring system 20. For instance, the catheterconnector can be a luer-type connector without a spin nut. Those skilledin the art can readily select the type of connector to be used with thepresent anchoring system 20 and can modify the anchoring systemaccording to the teachings of the present invention to suit theparticular application (e.g., venous, arterial, epidural, peripheral,etc.).

As best seen in FIGS. 1 and 2A, the connector 22 comprises a tubularbody 34 defined between a distal end 36 and a proximal end 38. Theproximal end 38 is adapted to receive a distal end of the tube 24. In anexemplifying embodiment, at least a portion the fluid tube 24 ispermanently attached to (e.g., embedded within) the proximal end 38 ofthe connector body 34.

The distal end 36 is configured to engage the proximal hub 32 of thecatheter 14 (see FIG. 1) or of any luer-type female connector. In theillustrated embodiment, the distal end 36 of the connector 22 isconfigured as a male luer portion 40 to be inserted into a standardreceptacle of a luer-type catheter hub 32. The distal end 36, however,can be configured to engage other types of catheter connectors, such as,for example, a Toughy-Bourst adaptor. As seen in FIG. 2A, the male luerportion 40 has a frusto-conical shape and extends distally from thetubular body 34. A tapered shoulder 42 is disposed between the tubularbody 34 and the male luer portion 40.

A central lumen extends through the tubular body 34 and the male luerportion 40, and terminates at a distal opening at the distal end 36 ofthe male luer portion 40. A proximal end of the central lumencommunicates with the fluid tube 24.

With reference to FIGS. 2A and 2B, the proximal end 38 of the connector22 includes a series of axially extending splines 44 projecting outwardfrom the tubular body 34. In particular, the connector 22 includes atleast one central, axially elongated spline 44 a, a pair of intermediatesplines 44 b disposed on either side of the central spline 44 a, and athird pair of outer splines 44 c that are substantially diametricallyopposed to each other. The central spline 44 a lies at a position 90°apart from each outer spline 44 c. The central spline 44 a also has agenerally rectangular shape that tapers to a point on both longitudinalends of the rectangular body. The second and third pair of splines 44 b.44 c form generally rectangular radial projections. The splines 44 arespaced around half of the circumference of the connector's tubular body34, as best seen in FIG. 2B.

As seen in FIG. 2A, the central spline 44 a has a longitudinal lengthL₁, and each spline 44 b, 44 c of the second and third pairs of splineshas a longitudinal length L₂. In addition, the distal end or tip of theelongated central spline 44 c is spaced from the proximal end 38 of thetubular body 34 by a longitudinal length L₃. In the illustratedembodiment, longitudinal length L₃ is longer than longitudinal lengthL₁, and L₁ is longer than longitudinal length L₂.

The connector 22 also includes a spin nut 46 disposed on its distal end36. The spin nut 46 comprises a generally tubular sleeve having acylindrical exterior surface, a proximal annular flange, and a series ofaxially extending grip rails. The spin nut 46 has three distinctinterior surface regions. A first distal region includes single ormultiple internal threads. The proximal end of the distal regionterminates at an intermediate region comprising an anti-rotational,friction enhancing structure such as an annular internal ramp (notshown) that cooperates with the tapered shoulder. Finally, a proximalregion includes a plurality of radially and inwardly directed ribsseparated by channels or guideways (not shown).

The radially inwardmost edges of the inner ribs on the spin nut 46define a circle having approximately the same diameter as the tubularbody 34 of the connector 22. The ribs are so dimensioned to interfit insliding engagement between the splines 44 along guideways. Conversely,the splines 44 extend into the channels between the ribs. Thecircumferential dimensions of the ribs and guideways may provide aslight interference tolerance to indicate when the spin nut 46 andtubular body 34 are rotationally locked.

Further description and alternative embodiments are described in, butnot limited to, the disclosure of the U.S. Pat. No. 5,620,427 toWerschrnidt et al.

Retainer

FIGS. 3 through 10 illustrate the retainer 30, which is configured inaccordance with a preferred embodiment of the present invention. Theretainer 30 has a body 50 that defines a central channel 52 disposedabove a base surface 54. The channel 50 extends about a central,longitudinally extending axis C and has an opening 56 that faces awayfrom the base surface 54. The proximal and distal ends of the channel 52also open through the ends of the retainer body 50. At least a portionof the channel 52 has a lateral width that is smaller than the diameterof the connector tubular body 34, as described below in greater detail.

FIG. 6 illustrates that the channel axis C is desirably skewed relativeto a base surface 54 of the retainer 30. An incident angle θ definedbetween the base surface 54 and the channel axis C preferably is lessthan 45°. More preferably, the incident angle θ ranges between 5° and30°. In an exemplifying embodiment for intravenous use, the angle θpreferably equals approximately 7°. In another exemplifying embodimentfor arterial use, the incident angle θ preferably equals about 22°.

As best seen in FIGS. 3, 4 and 10, the retainer 50 also includes aplurality of abutment surfaces the extends laterally from the channel52. Each abutment surface lies generally normal to the central axis C ofthe channel 52. These abutment surfaces include a proximal-most abutmentsurface 60, a distal-most abutment surface 62 and an intermediatesurface 64. The intermediate surface 64 lies between the proximal- anddistal-most abutment surfaces 60, 62 and is defined on a flexible wall66 so as to be movable relative to at least one of the abutment surfaces60, 62. The proximal- and distal-most abutment surfaces 60, 62preferably are separated by a distance that is generally equal to thelongitudinal length L₃ between the proximal end 26 of the connectortubular body 34 and a distal tip of the central spline 44 a.

In a more preferred mode, the flexible wall 66 includes two intermediateabutment surfaces: an intermediate proximal abutment surface 68 and anintermediate distal abutment surface 64. These abutment surfaces 64, 68face each other and are spaced apart by a distance that is generallyequal to the longitudinal length L₂ of the intermediate and outersplines 44 b, 44 c.

The illustrated embodiment of the retainer 30 includes an additionalpenult-proximate abutment surface 70 disposed between the proximal-mostabutment surface 60 and the intermediate proximal abutment surface 68.The penult-proximate abutment surface 70 lies generally normal to thecentral axis C of the channel 52 and is distanced from the distal-mostabutment 62 surface by the longitudinal length L₁ of the central spline44 a. In a variation of the retainer, the proximal-most abutment surfacecan be omitted when the retainer includes this additional abutmentsurface that cooperates with the proximal end of the central spline 44a.

As seen in FIG. 3, the retainer body 50 includes proximal and distal endportions 72, 74 and an intermediate portion 76. The channel 52 extendsthrough these portions 72, 74, 76 and is open at each of its endsthrough end walls of the proximal and distal end portions 72, 74.

With reference to FIGS. 3, 4, 9 and 10, the intermediate portion 76 isformed by a pair of flexible walls 66 between which the channel 52passes. Transversely extending slots 78 separate each flexible wall 66from the adjacent proximal and distal end portions 72, 74, and an outerside of each wall 66 includes a relief 80 that reduces the lateral widthof the wall 66 relative to the adjacent proximal and distal end portions72, 74. The relief 80 extends from its base 82 to an upper edge 84 ofthe wall 66, and preferably has a transverse height at least as large ashalf the diameter of the connector tubular body 34, and more preferably,at least as large as the diameter of the connector tubular body 34. Thiswall structure allows the wall 66 to deflect laterally outwardly,relative to the adjacent proximal and distal end portions 72, 74 of theretainer body 50.

Each flexible wall 66 also includes an intermediate proximal abutmentsurface 68 and an intermediate distal abutment surface 64. Theseabutment surfaces 64, 68 are formed on an inner side of the wall, and inthe illustrated embodiment, are disposed near the proximal and distalends of the wall 66. Each intermediate abutment surface 64, 68preferably extends in the transverse direction along the entire heightof the wall. In the illustrated embodiment, the lateral width of eachabutment surface 64, 68 also is at least as large as half the radialdimension of each spline of the second and third pairs of splines 44 b,44 c, and preferably is at least as large as the radial dimension.

Each flexible wall 66 additionally has a generally flat, upstandingsurface 86 defined between the opposing abutment surfaces 64, 68. Endstrips 88 are defined on either side of the flat surface 86. An upperend 90 of each end strip 88 curves inwardly toward a center of thechannel opening 56. The radius of curvature preferably matches or atleast approximates the radius of the connector tubular body 34. Theupper ends 90 of the end strips 88 thus reduce the lateral width of thechannel opening 56 as defined between the opposing end strip upper ends90. In this manner, the flexible walls 66 either grip onto or at leastextend over an upper section of the connector tubular body 34 to inhibitunintentional transverse movement of the connector 22 once situatedwithin the retainer 30.

As best seen in FIG. 9, the upper sides surfaces of the end strip upperends 90 preferably are rounded or chamfered and slop toward the channelopening 56 to guide the connector tubular body 34 or the elongatedcentral spline 44 a into the channel 52. As a result, the connector 22slides more smoothly over the end strip upper ends 90 and into thechannel 52 as the flexible walls 66 are deflected outwardly by theinterference with the connector 22 during the insertion process.

As seen in FIGS. 3, 4, 8, 9 and 10, the distal end portion 74 defines adistal section 92 of the channel that also inhibits unintentionaltransverse movement of connector 22. For this purpose, the distalchannel section 92 has a generally truncated, circular cross-sectionalshape that extends through an arc of greater than 180°. The distalchannel section 92 has a diameter sized to receive the tubular body 34of the connector 22. In an exemplifying embodiment, the distal channelsection 92 extends through an arc of about 200° about the channel axisc. The channel section 92, in cross-section, thus extends through an arcof a little more than 180° about the channel axis c such that thelateral width of the opening 56 is slightly smaller to the overalldiameter of the channel section 92. This allows for the connector 22 tobe snapped into the central channel 52.

The distal end portion 74 includes side walls 94 between which thedistal channel section 92 is defined. The side walls 92 aresubstantially identical and extend longitudinally from a point next tothe corresponding flexible wall 66 to the distal end of the retainer 30.

As appreciated from FIGS. 3 and 8, the upper edges 96 of the side walls94 preferably are rounded or chamfered and slop toward the distalchannel section 92 to guide the connector tubular body 34 into thechannel 52. As a result, the connector 22 slides more smoothly over theupper edges 96 of the side walls 94 and into the channel 52 as the walls94 are deflected outwardly by the interference with the connector body34 during the insertion process.

The walls 94 preferably wrap around a sufficient amount of the connector22 to inhibit unintentional transverse movement of the connector 22relative to the retainer 30. As understood from the above description,the upper ends of the walls 94 curve inwardly to narrow the lateralwidth of the channel opening 56. The extent to which the upper ends canextend inward is limited, however, in order to permit insertion of theconnector 22 into the channel 52 through the opening 56. Accordingly,the walls 94 preferably have a length sufficient to produce the desiredretention strength to hold the connector 22 in the retainer 30 againstan upwardly directed force (or force component). Of course, where theretainer 30 includes one or more additional mechanisms to resisttransverse movement of the connector 22 relative to the retainer 30—forexample, increased longitudinal lengths of flexible wall end strips 88or a snap fit connection between the connector 22 and the proximal endportion 72 of the retainer 30—the length of the walls 94 can be reduced.

In a preferred mode, the walls 94 also have a sufficient length toprevent the connector 22 from yawing (i.e., movement side to side in alongitudinal-lateral plane). That is, the length of the walls 94, whichinteracts with the connector 22, is sufficient so that the distal endportion 74 does not act as a fulcrum. However, while such wall length ispreferred, the wall length can be significantly shorter (e.g., interactwith the connector at a single longitudinal point) where the connectorbody 34 is also held near its proximal end by the flexible walls 66and/or by the proximal end portion 72.

Each wall 94 has a lateral thickness that decreases from the basesurface 54 of the retainer 30 to the top of the retainer 30. Inaddition, as best seen in FIG. 9, the distal channel section 92 isnotched along its base. The resulting relief 98 extends transverselyfrom the channel section 92 toward the base surface 54 andlongitudinally through the distal end portion 74. In the illustratedembodiment, the relief 98 has a generally rectangular cross-sectionalshape. The relief 98 also has a lateral width less than the diameter ofthe distal channel section 92, and preferably has a lateral widthapproximately equal to two-thirds the diameter of the distal channelsection 92. The decreased lateral thickness of the walls 94 and thedecrease transverse thickness of the distal end portion 74 below thechannel 52, as a result of the relief 98, provides increased flexibilityto permit the walls 94 to deflect elastically outwardly when pressingthe connector tubular body 34 into the channel 52.

The retainer 30 also include a notch 100 that extends longitudinallyalong the base surface 54 and beneath at least the distal channelsection 92. In the illustrated embodiment, the notch 100 runs along theentire longitudinal length of the retainer 30. The notch 100 alsodecreases in traverse height from it proximal end to its distal endfollowing the slope θ of the channel 52. The lateral width of the notch100 is less than the diameter of the of the central channel 52. Thisnotch 100 also enhances the flexible nature of the side walls 94.

The side walls 94, however, are substantially more rigid than theflexible walls 66. That is, greater force is required to laterallydeflect the side walls 94 of the distal end portion 74 than is requiredto laterally deflect the flexible walls 66.

As seen in FIGS. 5, 7 and 8, a pair of ridges 102 flank the notch 100.Each ridge 102 extends slightly below the base surface 54 to inhibit aninflux of adhesive into the notch 100 when the retainer is attached tothe anchor pad 28.

The proximal ends of the side walls 94 define at least a portion of thedistal-most abutment surface 62. Thus, the distal-most abutment surface62 constitutes the distal side of each slot 78 between the correspondingside walls 94 and the flexible walls 66. In the illustrated embodiment,the distal-most abutment surface 62 is generally upright.

As seen in FIGS. 4, 5, 9 and 10, a recess 104 is defined in the retainerbody 50 at a point between the proximal and distal end portions 72, 74and between the flexible walls 66, and extends toward the base surface54 from the channel 52. In the illustrated embodiment, the recess 104extends between the channel 52 and the base surface 54 in order toreduce the material weight of the retainer 30; however, the recess 104need only be deep enough to receive one or more of the splines 44 thatmay extend downward when the connector 22 is inserted into the retainer30. The recess 104 interrupts the base notch 100, and the channel relief98 opens into the recess 104 at its proximal end.

The recess 104 is defined by a proximal wall and a distal wall. Thedistal wall is formed by a proximal end surface of the distal endportion 74 of the retainer 30 and the proximal wall is formed by adistal end surface of the proximal end portion 72 of the retainer 30.Both of these walls lie generally normal to the central axis c of thechannel 52 and lie generally in an upright position. The spacing betweenthe walls preferably is as long as the longitudinal length L₁ of thecentral spline 44 a. In the illustrated embodiment, the distal wallforms a portion of the distal-most abutment surface 62, and the proximalwall forms a portion of the penult-proximate abutment surface 70.Accordingly, the distal-most abutment surface 62 is formed on theproximal ends of the side walls 94 of the distal end portion 74 and onthe distal wall of the recess 104. The penult-proximate abutment surface70 is formed on the proximal wall of the recess 104.

The proximal end portion 72 defines a proximal section 106 of thechannel 52 between the penult-proximate abutment surface 70 and theproximal-most abutment surface 60. The proximal section 106 of thechannel 52 generally has a U-shaped cross-section with a radius ofcurvature at least as large as the radius of the connector tubular body34. The radius of curvature preferably is larger than the radius of theconnector tubular body 34.

The proximal end portion 72 also includes a proximal upstanding wall 108that extends laterally across the proximal end of the retainer 30. Theupstanding wall 108 includes a U-shaped opening 110 that defines theproximal end of the channel 52. The opening 110 has a lateral width thatis smaller than the diameter of the connector tubular body 34, but islarger than the diameter of the fluid tube 24. In the illustratedembodiment, the proximal upstanding wall 108 defines the proximal-mostabutment surface 60 on its distal side. The proximal-most abutmentsurface 60 thus, in the illustrated embodiment, lies at the proximal endof the channel proximal section 106.

Both the proximal opening 110 and the proximal section 106 of thechannel 52 have generally U-shapes; however, one or both of thesechannel sections can have a truncated, generally circular shape. In thisvariation, the opening or the proximal channel section can receive thefluid tube or the proximal end of the connector tubular body,respectively, in a snap fit manner, similar to the distal end portion ofthe retainer, to inhibit further transverse movement of the connectorrelative to the retainer. It is preferred, however, that these channelsections do not so engage the connector body or fluid tube in order toease the insertion process, as described below.

As illustrated in FIG. 3, the retainer 30 includes finger platforms 112on both sides of the central channel 52. Each finger platform 112extends laterally from one side of the retainer 30 at a locationslightly above the base surface 54. Each finger platform 112 also has aribbed upper surface to improve frictional contact between a healthcareprovider's fingers and the platform 112. The finger platforms 112 aresized and configured to allow a healthcare provider to press theretainer 30 against the skin of the patient while pulling up on theconnector 22 when disengaging the connector 22 from the retainer 30.

The combination of the finger platforms 112 and the notch 100 along thebase surface 54 beneath the channel 52 makes it easier for thehealthcare provider to open the channel 52 to a sufficient degree so asto insert the connector tubular body 34 into the channel 52. This aspectof the anchoring system 20 is not limited to the present retainer.Rather, it can be applied to other types of retainers as well, such as,for example, but without limitation, to those described in U.S. Pat.Nos. 5,702,371, 5,810,781, and 5,827,230, which are hereby incorporatedby reference.

The retainer 30 is made of relatively stiff plastic material (e.g.,polycarbonate), but is somewhat flexible such that the connector 22 willforce the walls 94 of the distal end portion 74, and under somesituations the flexible walls 66, outwardly when a healthcare providerpresses the connector 22 into the central channel 52 of the retainer 30.When the connector 22 sits in the central channel 52, the upper edges 96of the walls 94 (and the upper end 90 of the end strips 88) snapinwardly to their original position to securely hold the connector 22within the retainer 30.

The retainer 30 may be constructed in any of a variety of ways whichwill be well known to one of skill in the art. For instance, retainer 30may be integrally molded such as by injection molding or bythermoplasty. The retainer 30 preferably comprises a durably, flexiblematerial, and more preferably comprise a generally inert, non-toxicmaterial. Suitable materials include plastics, polymers, or compositessuch as polypropylene, polyethylene, polycarbonate, polyvinylchloride,polyurethane, tetrafluoroethylene (e.g., TEFLON®),polytetrafluoroethylene (a.k.a., PTEF), acetal resin (e.g., DELRIN®),chlorotrifluoroethylene (e.g., KEL-F®), acrylonitrile butadiene styrene,styrene butadiene, nylon, olefin, acrylic, polyester, moldable silicon,thermoplastic urethane, thermoplastic elastomers, thermoset plastics andthe like. The retainer 30 is preferably formed by injection moldingusing a polycarbonate, available commercially from GE Plastics (Seewww.geplastics.com). However, other materials can be used.

Anchor Pad

As is seen in FIG. 1, the anchor pad 28 is a substantially flat piece ofmaterial with transversely opposing sides. The lower side of the pad 28faces toward the skin of the patient, and is preferably covered with anadhesive surface suitable for attaching the anchor pad 28 to the skin ofthe patient. The entire surface, however, need not be covered. An upperside 120 of the anchor pad 28 faces away from the skin of the patientand supports the retainer 30.

The anchor pad 28 preferably comprises a laminate structure with anupper foam layer (e.g., closed-cell polyethylene foam) and a loweradhesive layer. The lower adhesive layer constitutes the lower surfaceof the anchor pad 28, i.e., it is coextensive with the upper foam layer.The lower surface desirably is a medical-grade adhesive and can beeither diaphoretic or nondiaphoretic, depending upon the particularapplication. Such foam with an adhesive layer is available commerciallyfrom Tyco Adhesives of Norwood, Mass.

A surface of the upper foam layer constitutes the upper surface 120 ofthe anchor pad 28. The upper surface 120 can be roughened by chemicalpriming or by corona-treating the foam with a low electric charge. Theroughened or porous upper surface 120 can improve the quality of theadhesive joint (which is described below) between the base 54 and theanchor pad 120. In the alternative (not shown), the flexible anchor pad28 can comprise a medical-grade adhesive lower layer, an inner foamlayer and an upper paper or other woven or non-woven cloth layer.

The anchor pad 28 generally has a rectangular shape with rounded cornersand elongated extensions that project from the generally rectangularshape. In the illustrated embodiment, these extensions take the form ofstrips or wings 122 that project from the lateral sides of the anchorpad 28. Each wing 122 preferably has a lateral length that is greaterthan the circumference of the fluid tube 24 to permit the wing 122 to bewrapped around the tube 24, as illustrated in FIG. 1. The longitudinalwidth of the wing 122 is sufficient to inhibit the wing 122 from beingtorn from the anchor pad 28.

In the illustrated embodiment, the wings 122 extend on both lateralsides of the anchor pad 28 to give the healthcare provider the option onwhich side to form a safety loop. The anchor pad 28, however, caninclude only one wing or more than two wings. Each wing 122 preferablylies distally of the retainer 30, although the wings 122 can extend fromother locations on the anchor pad 28 and/or can have differentorientations relative to the retainer 30 (e.g., be skewed relative tothe lateral axis) in order to suit particular applications.

This aspect of the anchoring system—an anchor pad including one or morewings to form a safety loop—is not limited to the particular shape ofthe anchor pad of the illustrated embodiment. It also is not limited touse with the present retainer. Rather, this aspect can be applied inanchoring systems that use other types of retainers, including thosenoted above, or that employ other anchoring techniques.

The anchor pad 28 also includes a concave section or notch 124, as shownin FIG. 1, that narrows the center of the anchor pad 28 proximate to theretainer 30 and on a distal side of the pad 28. The notch 124facilitates viewing the indwelling catheter 26, cleansing the insertionsite, and placing the anchor pad 28 about the insertion site. This shapealso permits the anchor pad 28 to be placed on the patient such that theanchor pad extends beyond the insertion site on the distal side, andaway from the insertion site on the proximal other. By aligning theanchor pad 28 and the insertion site of the catheter 26 in this manner,enhanced stability is provided to the catheter 26. This also minimizesthe free length of the catheter 26 between the insertion site and thechannel 52 of the retainer 30, helping prevent inadvertently catching orpulling on and dislodging of the catheter 26 as the patient moves or ashealthcare providers tend the patient.

Another concave section 126 also narrows the center of the anchor pad 28proximate to the retainer 30 on a proximal side of the pad 28. Theconcave sections 124, 126 together give the anchor pad 28 greaterflexibility at its midsection, thus allowing the anchor pad 28 to sitflat against the skin and follow any surface undulations (e.g., followthe curvature over the patient's knuckles).

The retainer 30 is preferably centered upon the anchor pad 28 about anaxis which bifurcates the concave sections 124, 126. Consequently thelateral sides of the anchor pad 28 have more contact area with the skin,both distally and proximally of the retainer 30 in the longitudinaldirection, which provides greater stability and adhesion to the skinwhile still permitting the retainer 30 to be located near the insertionsite. Although not illustrated, the anchor pad 28 also can includesuture and/or breather holes which are positioned to the sides of theretainer 30.

The retainer base 54 is attached to the upper surface 120 of the anchorpad 28. The bottom surface 54 preferably is secured to the upper surface120 by a solvent bond adhesive, such as cyanoacrylate or other bondingmaterial. One such adhesive is available commercially as Part No. 4693from the Minnesota Mining and Manufacturing Company (3M).

A removable paper or plastic release liner (not shown) desirably coversthe adhesive lower surface before use. The release liner preferablyresists tearing and desirably is divided into a plurality of pieces toease attachment of the anchor pad 28 to a patient's skin. In theillustrated embodiment, the release liner is split along a centerline ofthe anchor pad 28 in order to expose only half of the adhesive lowersurface at one time. In addition, the release liner is kiss-cut at thebase of each wing 122 such that the adjacent half of the adhesivesurface can be exposed without removing the portion of the release linerthat covers the wing 122.

The length of each release liner piece, as measured in the lateraldirection, extends beyond the centerline of the anchor pad 28 and isfolded over, or back onto the release liner. This folded over portiondefines a pull-tab to facilitate removal of the release liner from theadhesive lower surface. A healthcare worker uses the pull-tab bygrasping and pulling on it so that the release liner is separated fromthe lower surface. The pull-tab eliminates the need to pick at a corneredge or other segment of the release liner in order to separate therelease liner from the adhesive layer. The pull-tab of course can bedesigned in a variety of configurations. In addition, the pull-tab neednot be located along a centerline of the anchor pad 28; rather, thepull-tab can be located along any line of the anchor pad 28 in order toease the application of the anchor pad 28 onto the patient's skin at aspecific site. For example, an area of a patient's skin with an abruptbend, such as at a joint, may require that the pull-tab be alignedtoward one of the lateral sides of the anchor pad 28 rather than alongthe centerline.

Method of Use

The following discussion of the method of use will be with reference toFIGS. 1 and 11-12, and will be in the context of intravenouscatheterization. As the following discussion will illustrate, however,it is understood that the anchoring system 20 can be used in othercatheterization procedures as well. The discussion of the method of useis intended to augment the above description of the invention, and,thus, should be read together.

A healthcare provider typically begins the catheterization process bypositioning the catheter 26 at a desired location above a vein. Thehealthcare provider introduces a needle or other stylus through acannula portion of the catheter 26 and into the skin of the patient at adesired angle of incident. For intravenous use, the catheter 26 commonlyhas an incident angle of approximately 7°. The healthcare provider theninserts the cannula of the catheter 26 into the patient and withdrawsthe needle or stylus. Part of the catheter 26 remains exposed above theskin. The healthcare provider inserts the proximal end of the connector22 into the catheter hub 32. The healthcare provider then securelyattaches the connector 22 to the catheter 26 by engaging the spin nut 46with the catheter hub 32 in a known manner.

The healthcare provider positions the retainer 30 below the connector 22and inserts a portion of the fluid tube 24 through the proximal opening110. At this point, the axis of the connector 22 is skewed relative tothe axis c of the retainer channel 52. The healthcare provider pulls thefluid tube 24 proximally (or conversely slides the retainer distally)until the proximal end 38 of the connector tubular body 34 contacts theproximal-most abutment surface 60. This act registers the longitudinalposition of the connector 22 with the retainer 30 to align the connector22 above the retainer 30. So positioned, the longitudinal midpoint ofthe splines 44 on the connector 22 is aligned with the longitudinalmidpoint of the flexible walls 66 of the retainer 30 and with thelongitudinal midpoint between the penult-proximate and distal-mostabutment surfaces 70, 62. The healthcare provider then presses theconnector 22 into the central channel 52 of the retainer 30. In doingso, the connector 22 is pressed between the distal end portion walls 94of the retainer 30. As the healthcare provider presses the connector 22into the retainer 30, the splines 44 are generally guided into eitherthe space between the intermediate proximal and distal and abutmentsurfaces 64, 68 or the space between the penult-proximate abutmentsurface 70 and the distal-most abutment surface 62.

As mentioned above, the opening 56 of the channel 52 has a smaller widthmeasured in the lateral direction than the diameter of the connectortubular body 34. The distal end portion walls 94 thus deflect outwardlyin a lateral direction. Once the tubular body 34 of the connector 22rests within the central channel 52 of the retainer 30, the lateralwalls 94 spring back to snap the connector 22 in place. The walls 94 ofthe retainer 30 thus prevent unintentional transverse and lateralmovement of the connector 22. As noted above, the flexible walls 66 alsodeflect and snap around the tubular body 34 during the insertionprocess.

Once the connector 22 is secured in the retainer 30, the healthcareprovider removes the paper backing which initially cover the adhesivebottom surface of the anchor pad 28, and attaches the pad 28 to thepatient's skin proximate to the indwelling catheter 26. Specifically,the healthcare provider grips the one of the two backing tabs. Thehealthcare provider then pulls on the tab and peels the backing off oneside of the bottom adhesive layer. The healthcare provider positions theanchor pad 28 over the placement site and places the exposed bottomlayer against the patient's skin to adhere the anchor pad 28 to thepatient. Light pressure over the upper layer 120 assures good adhesionbetween the anchor pad 28 and the patient's skin. The anchor pad 28, dueto its flexibility, conforms to the contours of the topical surface towhich the anchor pad 28 adhere.

The healthcare provider repeats this procedure for the other side of thebottom surface of the anchor pad 28. Alternatively, the healthcareprovider may completely remove the backing from the pad 28 beforeattaching the pad 28 to the patient's skin. Additionally, the anchor pad28 can be attached to the patient before the connector 22 is insertedinto the retainer 30.

Either before or after the anchor pad 28 is attached to the patient'sskin, the healthcare provider secures a portion of the fluid tube 24 tothe anchor pad 28 using one of the elongated wings 122 to form a safetyloop. The healthcare provider removes the backing under the wing 122 onwhat ever side of the anchor pad 28 he or she elects to attach the tube24, and wraps the wing 122 around the tube 24 with the adhesive layercontacting the tube 24. In so doing, the distal end of the wing 122 isplaced on the tube 24, and the tube 24 is rolled toward the pad 28 toroll the tube 24 and the distal end of the wing 122 under the balance ofthe wing 122. This process continues until the wing 122 extends about asubstantial portion of the tube circumference. The healthcare providerpreferably wraps the wing 122 around the entire circumference.

The wing 122 on the other side of the anchor pad 28 can be attached tothe patient's skin by removing the backing and applying light pressure.This step can be done when applying the rest of the anchor pad 28 to thepatient or after. Alternatively, the healthcare provider can cut theunused strip off the pad 28 if so desired. In some instances, thehealthcare provider may elect not to form a safety loop in this manner.Additionally, the anchoring system can include a clip, such as disclosedin U.S. Pat. No. 5,827,230, to form the safety loop.

FIGS. 11A-F illustrate how the retainer 30 prevents the longitudinalmovement of the connector 22 in both the proximal and distal directionsonce the connector 22 is positioned within the channel 52, irrespectiveof the position of the splines 44 when the connector 22 is inserted intothe retainer 30. In FIGS. 11A and 11B, the connector 22 is situated suchthat the elongated spline 44 a faces away from the retainer base surface54. When the connector 22 is situated as such and the healthcareprovider presses the connector 22 into the retainer 30, thediametrically opposed splines 44 c slide into the recesses or spacesbetween the intermediate proximal and distal abutment surfaces 68, 64.Once inserted fully, these abutment surfaces 68, 64 restrain thediametrically opposed splines 44 c and thus inhibit longitudinalmovement of the connector 22 in both the proximal and distal directions.

In FIGS. 11C and 11D, the connector 22 is situated such that theelongated spline 44 a is rotated about 90° from its position in FIG.11A. As the connector 22 is inserted as situated, the elongated spline44 a contacts and pushes laterally and outwardly one of the flexiblewalls 66, and accordingly, the intermediate proximal and distal abutmentsurfaces 64, 68 are also moved laterally. The longitudinal ends of theelongated spline 44 a fall between the penult-proximate abutment surface70 and distal-most abutment surface 62. These abutment surfaces 70, 62longitudinally restrain the elongated spline 44 a and thus inhibit thelongitudinal movement of the connector 22 relative to the retainer 30.In particular, the distal-most abutment surface 62, against which thedistal end of the elongated spline 44 a acts when moved distally,inhibits longitudinal movement of the connector 22 in the distaldirection. The penult-proximate abutment surface 70, against which theproximal end of the elongated spline 44 a acts when moved proximally,inhibits proximal movement of the connector 22 in the proximaldirection.

In FIGS. 11E and 11F, the connector 22 is situated such that theelongated spline 44 a is rotated about 90° from its position in FIG. 11Cand about 180° from its position in FIG. 11A. In this case, thediametrically opposed splines 44 c are restrained as they were in FIG.11A, thus inhibiting the longitudinal movement of the connector 22. Inthis position, the elongated spline 44 a is situated within the recess104 below the channel 52. The distal-most abutment surface 62 and theintermediate distal abutment surface 64, against which the distal endsof the splines 44 a, 44 c respectively act when moved distally, togetherinhibits longitudinal movement of the connector 22 in the distaldirection. The penult-proximate abutment surface 70 and the intermediateproximal abutment surface 68, against which the proximal ends of thesplines 44 a, 44 c respectively act when moved proximally, togetherinhibits proximal movement of the connector 22 in the proximaldirection.

The preceding scenarios merely illustrate the functioning of theretainer 30. As will be readily apparent to one skilled in the art, nomatter what position the connector 22 and its splines 44 are in, atleast one of the splines 44 is retained by one or more of the retainer'sabutment surfaces and thus longitudinal movement of the connector isinhibited. For instance, at an intermediate position between thepositions illustrated in FIGS. 11A and 11B and in FIGS. 11C and 11D, atleast one of the intermediate splines 44 b is longitudinally restrainedbetween the intermediate proximal and distal abutment surfaces 68, 64.In this manner, longitudinal movement of the connector 22 in both theproximal and distal directions is restrained relative to the retainer30.

Additionally, the proximal-most abutment surface 60 arrests longitudinalmovement of the connector 22 in the proximal direction irrespective ofthe positions of the connector splines 44 when the connector 22 isinserted into the retainer 30. The proximal end 38 of the connector 22abuts or contacts the proximal-most abutment surface 60 of the retainer30 in every rotational position of the connector 22. Accordingly, theproximal-most abutment surface 60 also inhibits proximal movement of theconnector 22 along in the longitudinal direction.

As noted above, a variation of the retainer can eliminate thepenult-proximal and the intermediate proximate abutments surfaces 70, 68when the retainer includes the proximal-most abutment surface 60 toinhibit proximal movement. In another variation of the retainer, theproximal-most abutment surface 60 can be omitted when one or both of thepenult-proximate abutment surface 70 and the intermediate proximateabutment surface 68 are arranged to arrest proximal longitudinalmovement of the connector 22 relative to the retainer 30.

FIG. 12 illustrates the removal of the connector 22 from the retainer30. The healthcare provider places to two fingers on the fingerplatforms 112 and presses down slightly. The force from the pressure onthe finger platforms 112 causes the upper ends of side walls 94 and theflexible walls 66 to spread apart laterally. Consequently, the upperopening 56 of the retainer channel 52 opens to a size slightly greaterthan the diameter of the connector 22. The healthcare provider thenlifts the connector 22 out of the central channel 52.

The present anchoring system thus provide a sterile, tight-gripping,needle- and tape-free way to anchor a medical article to a patient. Theretainer eliminates use of tape, and if prior protocol requiredsuturing, it also eliminates accidental needle sticks, suture-wound-siteinfections and scarring. In addition, the retainer can be configured tobe used with any of a wide variety of catheters, fittings, tubes, wires,and other medical articles. Patient comfort is also enhanced andapplication time is decreased with the use of the present anchoringsystem.

Of course, it is to be understood that not necessarily all such objectsor advantages may be achieved in accordance with any particularembodiment of the invention. Thus, for example, those skilled in the artwill recognize that the invention may be embodied or carried out in amanner that achieves or optimizes one advantage or group of advantagesas taught herein without necessarily achieving other objects oradvantages as may be taught or suggested herein. In addition to thevariations described herein, other known equivalents for each featurecan be incorporated by one of ordinary skill in this art to constructanchoring system in accordance with principles of the present invention.

Although this invention has been disclosed in the context of a certainpreferred embodiment and variations thereof, it therefore will beunderstood by those skilled in the art that the present inventionextends beyond the specifically disclosed embodiments to otheralternative embodiments and/or uses of the invention and obviousmodifications and equivalents thereof. Thus, it is intended that thescope of the present invention herein disclosed should not be limited bythe particular disclosed embodiments described above, but should bedetermined only by a fair reading of the claims that follow.

What is claimed is:
 1. A retainer for securing a medical device havingan elongated tubular body having a proximal end and a distal end, andincluding at least first and second axially extending splines, thesecond axially extending spline having a greater longitudinal lengththan the first axially extending spline, the retainer comprising: a bodyhaving first and second end portions and a pair of flexible wallsdisposed at a longitudinal position along the body between thelongitudinal positions of the first and second end portions; a channelextending through at least the first and second end portions andextending at least partially between the pair of flexible walls, theflexible walls being deflectable away from a central axis of thechannel; and a pair of longitudinally opposed abutment surfaces, each ofwhich is formed on one or the other of the pair of flexible walls, theabutment surfaces lying generally normal to the central axis of thechannel and being spaced longitudinally apart from each other by adistance that generally corresponds to the longitudinal length of thefirst spline of the tubular body.
 2. The retainer of claim 1 wherein thefirst end portion of the body of the retainer defines a first additionalabutment surface that lies generally normal to the central axis of thechannel, the second end portion defining a second additional abutmentsurface that lies generally normal to the central axis of the channeland that generally opposes the first additional abutment surface, thefirst and second additional abutment surfaces being spaced from eachother by a distance greater than the longitudinal length of the secondspline of the tubular body.
 3. The retainer of claim 2, wherein thedistance between the first and second additional abutment surfacesgenerally corresponds to a longitudinal length measured between theproximal end of the connector tubular body and a distal end of thesecond spline.
 4. The retainer of claim 2, wherein the distance betweenthe first and second additional abutment surfaces generally correspondsto the longitudinal length of the second spline of the tubular body. 5.The retainer of claim 1 wherein the pair of longitudinally opposedabutment surfaces are both formed on one of the pair of flexible walls.6. The retainer of claim 5 wherein an additional pair of longitudinallyopposed abutment surfaces are formed on the other of the pair offlexible walls, the additional pair of abutment surfaces being spacedlongitudinally apart from each other by a distance that generallycorresponds to the longitudinal length of the first spline.
 7. Theretainer of claim 1, wherein at least one of the flexible walls includesan upper portion that projects inwardly such that a lateral width of anupper opening of the channel is less than a maximum lateral width of thechannel between the flexible walls.
 8. The retainer of claim 1, whereinthe body additionally includes a pair of laterally extending platforms,and a longitudinal notch that extends parallel to the central axis ofthe channel and runs along a bottom surface of the body.
 9. A retainerfor securing a medical article having an elongated body and a first anda second elongated member, each of which extends radially from thetubular body, the second elongated member having a greater longitudinallength than that of the first elongated member, the retainer comprising:a body; a channel extending through at least portion of the body, thechannel being configured to accept at least a portion of the elongatedbody of the medical article; and securing means for selectivelycapturing at least one of the first and second elongated members withinthe body regardless of the rotational orientation of the elongated bodyso as to inhibit axial movement of the elongated body within thechannel.
 10. The retainer of claim 9 further comprising means forcapturing the second elongated member when the second elongated membergenerally faces a bottom side of the body.
 11. The retainer of claim 9,wherein at least a section of the longitudinal channel has a generallytruncated circular cross-sectional shape which is sized to surround atleast a portion of the medical article through an arc of greater than180°.
 12. The retainer of claim 9, wherein at least a section of thechannel is generally U-shaped.
 13. The retainer of claim 9, wherein thebody additionally includes a pair of laterally extending platforms, anda longitudinal notch that extends parallel to the axis of the channeland runs along a bottom surface of the body.
 14. A method of releasablyanchoring an elongated medical article having at least first and secondsplines with differing end points along the length of the medicalarticle, the method comprising: providing a retainer having a bodycomprising a pair of flexible walls and a channel which extends throughat least a portion of the body and extends at least partially betweenthe pair of flexible walls, and a pair of longitudinally opposedabutment surfaces, each of which is formed on one or the other of thepair of flexible walls, the abutment surfaces lying generally normal tothe central axis of the channel and being spaced longitudinally apartfrom each other by a distance that generally corresponds to thelongitudinal length of the first spline of the tubular body; andinserting at least a portion of the medical article into the channelwithout regard to the orientation of the splines relative to theretainer so that the splines may be in any of a plurality of positionswith respect to the retainer such that longitudinal motion of the medialarticle inhibited by the interaction of one or more of the splines withabutment surfaces.
 15. The method of claim 14 wherein providing aretainer further comprises providing an anchor pad upon which theretainer is disposed, the anchor pad having an adhesive disposed uponone side, and the method further comprises attaching the anchor pad tothe skin of a patient.